Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 1430-1432 [E6-59]

Download as PDF 1430 Federal Register / Vol. 71, No. 5 / Monday, January 9, 2006 / Notices development and the protection of public health, safety, and ethical standards, FDA has established human subject protection regulations addressing requirements for informed consent and institutional review board (IRB) review that apply to all FDAregulated clinical investigations involving human subjects. In particular, informed consent requirements further both safety and ethical considerations by allowing potential subjects to consider both the physical and privacy risks they face if they agree to participate in a trial. Under FDA regulations, clinical investigations using human specimens conducted in support of premarket submissions to FDA are considered human subject investigations (see 21 CFR 812.3(p)). Many IVD device studies are exempt from most provisions of part 812 (21 CFR part 812), Investigational Device Exemptions (IDEs), under § 812.2(c)(3), but FDA’s regulations for the protection of human subjects (parts 50 and 56 (21 CFR parts 50 and 56)) apply to all clinical investigations that are regulated by FDA (see §§ 50.1 and 56.101, and section 520(g)(3)(A) and (g)(3)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(3)(A) and (g)(3)(D))). FDA regulations do not contain exceptions from the requirements of informed consent on the grounds that the specimens are not identifiable or that they are remnants of human specimens collected for routine clinical care or analysis that would otherwise have been discarded. Nor do FDA regulations allow IRBs to decide whether or not to waive informed consent for research involving leftover or unidentifiable specimens. FDA intends to notify the public, in a level 1 guidance document issued under the good guidances practices regulation (21 CFR 10.115), of the circumstances in which it intends to exercise enforcement discretion as to the informed consent regulations for clinical investigators, sponsors, and IRBs. In the guidance document, FDA recommends that sponsors of studies that meet the conditions maintain documentation of how these conditions were met and of the types of human subject protection procedures followed by the specimen provider to ensure that the subject cannot be identified. Sponsors that wish to follow the recommendations of the guidance will substitute use of records to demonstrate conformance to this enforcement discretion policy in place of the more detailed and patient-specific records for obtaining and documenting informed consent. Most fundamentally, this means collecting and maintaining information about the protections that are in place to prevent the identification of the specimens, since making sure that the specimens are not identifiable is key to obtaining FDA’s enforcement discretion. FDA intends to exercise enforcement discretion when all the following are true: • The investigation meets the IDE exemption criteria at § 812.2(c)(3); • The study uses leftover specimens, that is, remnants of specimens collected for routine clinical care or analysis that would have been discarded if not used in the study; • The specimens provided to the investigator are accompanied by only minimal clinical information such as age, gender, and existing laboratory result; • The specimens are not individually identifiable; • The specimens are provided to the investigator(s) without identifiers and the supplier of the specimens has established policies and procedures to prevent the release of personal information; • The individuals caring for the patients are different from, and do not share information with, those conducting the investigation; and • The study has been reviewed by an IRB in accordance with 21 CFR part 56. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 Annual Frequency per Record No. of Recordkeepers 600 1There Total Annual Records 1 600 Total Hours 4 2,400 are no capital costs or operating and maintenance costs associated with this collection of information. The recommendations of this guidance impose a minimal burden on industry. FDA estimates that 600 studies will be affected annually. Each study will result in one recordkeeping per year, estimated to take 4 hours to complete. This results in a total recordkeeping burden of 2,400 hours (600 × 4 = 2,400). DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2005M–0320, 2005M–0289, 2005M–0387, 2005M–0270, 2005M–0379, 2005M–0388, 2005M–0284, 2005M–0283, 2005M–0328, 2005M–0308, 2005M–0380, 2005M–0321, 2005M–0339, 2005M–0359, 2005M–0382, 2005M–0381, 2005M–0378] Dated: January 3, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–73 Filed 1–6–06; 8:45 am] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications BILLING CODE 4160–01–S AGENCY: Food and Drug Administration, HHS. cprice-sewell on PROD1PC66 with NOTICES Hours per Record ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of VerDate Aug<31>2005 15:31 Jan 06, 2006 Jkt 208001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency’s Division of Dockets Management. Submit written requests for copies of summaries of safety and effectiveness to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices and Radiological Health (HFZ–402), Food and Drug Administration, 9200 E:\FR\FM\09JAN1.SGM 09JAN1 1431 Federal Register / Vol. 71, No. 5 / Monday, January 9, 2006 / Notices Corporate Blvd., Rockville, MD 20850, 301–594–2186. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the Federal Register. Instead, the agency now posts this information on the Internet on FDA’s home page at https://www.fda.gov. FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the Federal Register, and FDA believes that the Internet is accessible to more people than the Federal Register. In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from July 1, 2005, through September 30, 2005. There were no denial actions during this period. The list provides the manufacturer’s name, the product’s generic name or the trade name, and the approval date. TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 2005, THROUGH SEPTEMBER 30, 2005 PMA No./Docket No. Applicant Trade name Approval date W.L. Gore & Associates, Inc. GORE TAG THORACIC ENDOPROSTHESIS March 23, 2005 P030035(S3)/2005M–0289 St. Jude Medical FRONTIER MODEL 5508L AND FRONTIER II MODEL 5586 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRTP) SUPPORTED ON THE MODEL 3510 PROGRAMMER PLATFORMS WITH THE MODEL 3307, V4.8M PROGRAMMER SOFTWARE April 29, 2005 P040005/2005M–0387 DakoCytomation Denmark A/S DAKOCYTOMATION HER2 FISH PHARMDX KIT May 3, 2005 P030049/2005M–0270 Bayer Healthcare, LLC ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL May 26, 2005 P040037/2005M–0379 W.L. Gore & Associates, Inc. VIABAHN ENDOPROSTHESIS June 14, 2005 P040011/2005M–0388 DakoCytomation California, Inc. DAKOCYTOMATION C-KIT PHARMDX June 27, 2005 P950042(S3)/2005M–0284 Xillix Technologies Corp. ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA June 30, 2005 P970003(S50)/2005M–0283 Cyberonics, Inc. VNS THERAPY SYSTEM July 15, 2005 P030004/2005M–0328 Micro Therapeutics, Inc. ONYX LIQUID EMBOLIC SYSTEM July 21, 2005 H050001/2005M–0308 Boston Scientific Smart WINGSPAN STENT SYSTEM WITH GATEWAY PTA BALLOON CATHETER August 3, 2005 P030036/2005M–0380 cprice-sewell on PROD1PC66 with NOTICES P040043/2005M–0320 Medtronic, Inc. MEDTRONIC SELECTSECURE August 3, 2005 P040021/2005M–0321 St. Jude Medical, Inc. SJM BIOCOR VALVE/SJM BICOR SUPRA VALVE August 5, 2005 P040039/2005M–0339 Orthometrix, Inc. ORBASONE PAIN RELIEF SYSTEM August 10, 2005 VerDate Aug<31>2005 15:31 Jan 06, 2006 Jkt 208001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\09JAN1.SGM 09JAN1 1432 Federal Register / Vol. 71, No. 5 / Monday, January 9, 2006 / Notices TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 2005, THROUGH SEPTEMBER 30, 2005—Continued PMA No./Docket No. Applicant Trade name Approval date P040044/2005M–0359 Access Closure, Inc. MATRIX VSG SYSTEM MODEL MX–100 August 17, 2005 P930016(S21)/2005M–0382 Visx, Inc. STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) August 30, 2005 P040038/2005M–0381 Abbott Vascular Devices XACT CAROTID STENT SYSTEM September 6, 2005 P930014(S15)/2005M–0378 Alcon Laboratories ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENS September 14, 2005 II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/cdrh/pmapage.html. Dated: December 20, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6–59 Filed 1–6–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. cprice-sewell on PROD1PC66 with NOTICES This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on February 9, 2006, from 8 a.m. to approximately 5:30 p.m. and on February 10, 2006, from 8 a.m. to approximately 1 p.m. Location: Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Gail Dapolito or Rosanna L. Harvey, Food and Drug Administration, 1401 Rockville Pike (HFM–71), Rockville, MD 20852, 301– 827–0314 or FDA Advisory Committee Information Line, 1–800–741–8138 (301)–443–0572 in the Washington, DC area), code 301–451–2389. Please call VerDate Aug<31>2005 15:31 Jan 06, 2006 Jkt 208001 the Information Line for up-to-date information on this meeting. Agenda: On February 9, 2006, in open session, the committee will conduct a scientific discussion of potency measurements for cellular and gene transfer products. On February 10, in open session, the committee will (1) Discuss the National Toxicology Program on Retroviral Mutagenesis and (2) receive a brief update on the recent review of the research program of the Office of Cellular, Tissue and Gene Therapies, FDA. Procedure: On February 9, 2006, from 8 a.m. to approximately 5:30 p.m., and on February 10, 2006, from 8 a.m. to approximately 11:30 a.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by February 2, 2006. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2 p.m. on February 9, 2006, and between approximately 9:40 a.m. and 10:10 a.m. on February 10, 2006. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 2, 2006, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Closed Committee Deliberations: On February 10, 2006, from approximately 11:30 a.m. to 1 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)); and where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss the report of the Research Subcommittee of the PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 Cellular, Tissue and Gene Therapies Advisory Committee related to a review of the research program in the Office of Cellular, Tissue and Gene Therapies. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Gail Dapolito at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 3, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6–71 Filed 1–6–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0468] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.’’ This draft guidance document E:\FR\FM\09JAN1.SGM 09JAN1

Agencies

[Federal Register Volume 71, Number 5 (Monday, January 9, 2006)]
[Notices]
[Pages 1430-1432]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-59]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2005M-0320, 2005M-0289, 2005M-0387, 2005M-0270, 2005M-
0379, 2005M-0388, 2005M-0284, 2005M-0283, 2005M-0328, 2005M-0308, 
2005M-0380, 2005M-0321, 2005M-0339, 2005M-0359, 2005M-0382, 2005M-0381, 
2005M-0378]


Medical Devices; Availability of Safety and Effectiveness 
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
premarket approval applications (PMAs) that have been approved. This 
list is intended to inform the public of the availability of safety and 
effectiveness summaries of approved PMAs through the Internet and the 
agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety 
and effectiveness to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Please cite the appropriate docket number as listed in table 1 
of this document when submitting a written request. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices 
and Radiological Health (HFZ-402), Food and Drug Administration, 9200

[[Page 1431]]

Corporate Blvd., Rockville, MD 20850, 301-594-2186.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA 
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to 
discontinue individual publication of PMA approvals and denials in the 
Federal Register. Instead, the agency now posts this information on the 
Internet on FDA's home page at https://www.fda.gov. FDA believes that 
this procedure expedites public notification of these actions because 
announcements can be placed on the Internet more quickly than they can 
be published in the Federal Register, and FDA believes that the 
Internet is accessible to more people than the Federal Register.
    In accordance with section 515(d)(4) and (e)(2) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and 
(e)(2)), notification of an order approving, denying, or withdrawing 
approval of a PMA will continue to include a notice of opportunity to 
request review of the order under section 515(g) of the act. The 30-day 
period for requesting reconsideration of an FDA action under Sec.  
10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA 
begins on the day the notice is placed on the Internet. Section 
10.33(b) provides that FDA may, for good cause, extend this 30-day 
period. Reconsideration of a denial or withdrawal of approval of a PMA 
may be sought only by the applicant; in these cases, the 30-day period 
will begin when the applicant is notified by FDA in writing of its 
decision.
    The regulations provide that FDA publish a quarterly list of 
available safety and effectiveness summaries of PMA approvals and 
denials that were announced during that quarter. The following is a 
list of approved PMAs for which summaries of safety and effectiveness 
were placed on the Internet from July 1, 2005, through September 30, 
2005. There were no denial actions during this period. The list 
provides the manufacturer's name, the product's generic name or the 
trade name, and the approval date.

 Table 1.--List of Safety and Effectiveness Summaries for Approved PMAs
      Made Available From July 1, 2005, through September 30, 2005
------------------------------------------------------------------------
                                                              Approval
  PMA No./Docket No.       Applicant         Trade name         date
------------------------------------------------------------------------
P040043/2005M-0320     W.L. Gore &       GORE TAG THORACIC  March 23,
                        Associates,       ENDOPROSTHESIS     2005
                        Inc.
------------------------------------------------------------------------
P030035(S3)/2005M-     St. Jude Medical  FRONTIER MODEL     April 29,
 0289                                     5508L AND          2005
                                          FRONTIER II
                                          MODEL 5586
                                          CARDIAC
                                          RESYNCHRONIZATIO
                                          N THERAPY
                                          PACEMAKERS (CRT-
                                          P) SUPPORTED ON
                                          THE MODEL 3510
                                          PROGRAMMER
                                          PLATFORMS WITH
                                          THE MODEL 3307,
                                          V4.8M PROGRAMMER
                                          SOFTWARE
------------------------------------------------------------------------
P040005/2005M-0387     DakoCytomation    DAKOCYTOMATION     May 3, 2005
                        Denmark A/S       HER2 FISH
                                          PHARMDX KIT
------------------------------------------------------------------------
P030049/2005M-0270     Bayer             ADVIA CENTAUR      May 26, 2005
                        Healthcare, LLC   HBSAG READY PACK
                                          REAGENTS/
                                          CONFIRMATORY
                                          READY PACK
                                          REAGENTS/QUALITY
                                          CONTROL MATERIAL
------------------------------------------------------------------------
P040037/2005M-0379     W.L. Gore &       VIABAHN            June 14,
                        Associates,       ENDOPROSTHESIS     2005
                        Inc.
------------------------------------------------------------------------
P040011/2005M-0388     DakoCytomation    DAKOCYTOMATION C-  June 27,
                        California,       KIT PHARMDX        2005
                        Inc.
------------------------------------------------------------------------
P950042(S3)/2005M-     Xillix            ONCO-LIFE          June 30,
 0284                   Technologies      ENDOSCOPIC LIGHT   2005
                        Corp.             SOURCE AND VIDEO
                                          CAMERA
------------------------------------------------------------------------
P970003(S50)/2005M-    Cyberonics, Inc.  VNS THERAPY        July 15,
 0283                                     SYSTEM             2005
------------------------------------------------------------------------
P030004/2005M-0328     Micro             ONYX LIQUID        July 21,
                        Therapeutics,     EMBOLIC SYSTEM     2005
                        Inc.
------------------------------------------------------------------------
H050001/2005M-0308     Boston            WINGSPAN STENT     August 3,
                        Scientific        SYSTEM WITH        2005
                        Smart             GATEWAY PTA
                                          BALLOON CATHETER
------------------------------------------------------------------------
P030036/2005M-0380     Medtronic, Inc.   MEDTRONIC          August 3,
                                          SELECTSECURE       2005
------------------------------------------------------------------------
P040021/2005M-0321     St. Jude          SJM BIOCOR VALVE/  August 5,
                        Medical, Inc.     SJM BICOR SUPRA    2005
                                          VALVE
------------------------------------------------------------------------
P040039/2005M-0339     Orthometrix,      ORBASONE PAIN      August 10,
                        Inc.              RELIEF SYSTEM      2005
------------------------------------------------------------------------

[[Page 1432]]

 
P040044/2005M-0359     Access Closure,   MATRIX VSG SYSTEM  August 17,
                        Inc.              MODEL MX-100       2005
------------------------------------------------------------------------
P930016(S21)/2005M-    Visx, Inc.        STAR S4 IR         August 30,
 0382                                     EXCIMER LASER      2005
                                          SYSTEM WITH
                                          VARIABLE SPOT
                                          SCANNING (VSS)
------------------------------------------------------------------------
P040038/2005M-0381     Abbott Vascular   XACT CAROTID       September 6,
                        Devices           STENT SYSTEM       2005
------------------------------------------------------------------------
P930014(S15)/2005M-    Alcon             ACRYSOF TORIC      September
 0378                   Laboratories      POSTERIOR          14, 2005
                                          CHAMBER
                                          INTRAOCULAR LENS
------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
https://www.fda.gov/cdrh/pmapage.html.

    Dated: December 20, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-59 Filed 1-6-06; 8:45 am]
BILLING CODE 4160-01-S

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